Moderna announced new data on Wednesday suggesting that a new version of their COVID-19 vaccine will offer superior protection than its original shot formulation, based on studying antibodies generated by their new boosters in blood samples from trial participants.
The company said in a release that it plans to submit its data to the Food and Drug Administration in the coming weeks. If the FDA announces, doses of the updated vaccine and boosters may be ready to be shipped “as early as August.”
Moderna’s announcement comes ahead of a meeting with the regulator’s external vaccine advisers, scheduled for later this month, which will weigh key decisions on potential changes to COVID-19 boosters that could be administered this fall.
“Looking at this autumn’s infection season with the respiratory virus, with SARS-CoV-2, and the ongoing circulation of Omicron and its variants, we strongly believe that this data supports an update of the vaccine from the sequence we have been using for many years,” said Modern President Dr. Stephen Hoge to investors on Wednesday.
Modern data comes from testing a 50 microgram “bivalent” version of the vaccine. Unlike the current “monovalent” version of the vaccine, which was designed to target the original “ancestral” strain of the virus, Modern’s new booster doses will add a version of the vaccine targeted at the Omicron variant.
The company also said the booster “was generally well tolerated, with side effects comparable to a booster” of the original vaccine of the same size.
Moderna did not release data showing how the higher antibodies generated by its bivalent vaccine can be translated into actual efficacy against the virus. However, the company said it was optimistic that their findings would be sufficient to meet FDA guidelines for allowing updated shots.
“We have obviously been engaged with regulators globally, including the FDA in the United States, on the criteria for this study since the beginning of this year. And have reviewed these protocols and designed the study to meet this guidance,” Hoge said.
Pfizer and partner BioNTech also say they are testing new versions of their COVID-19 vaccine. The FDA has asked to see these results before meeting with the FDA’s Advisory Committee on Vaccines and Related Biological Products (VRBPAC) later this month.
Regulators have so far been wary of approving a change of shots too early, citing the possibility that the attack on new varieties could make the strategy meaningless – ongoing decisions to dump the current vaccine supply with only marginal improvements.
But federal health officials have said they hope a bivalent approach can offer broader protection. The mixture of vaccines may protect against not only Omicron, but also future variants of concern that are expected to drive an autumn and winter wave of infections.
Modern’s leaders said on Wednesday that the company has already worked on scaling up the production of components that will be necessary for the new booster.
“We are confident that over the next few months of hard work we will be able to deliver significant, large quantities of the updated bivalent booster. Hopefully sufficient to meet all the demand that is out there for this updated vaccine throughout the fall season,” in Hoge.
FDA officials have previously said that they expect the green light for a “booster change” to the COVID-19 vaccines will probably mean replacing the shots not only for booster doses, but also the primary series offered to adults who are still unvaccinated.
Modern executives told investors that they are also preparing to study the updated shots in children as well, but noted that it was possible that the FDA may not need these studies to give the green light for an update on dose delivery for all ages.
They cited the current process of deciding on updates to the US stockpile of flu shots, which do not rely on specific studies to show changes in different age groups.
Currently, only the shots from Pfizer-BioNTech are authorized for Americans. Modern request to allow vaccination with a smaller dose of its original vaccine is expected to go before the FDA’s advisory committee, VRBPAC, on 14 and 15 June.
“It’s important that before we go too far down the road to determine that data is needed, we need to hear from regulators, including the FDA in VRBPAC next week,” Hoge said.